Hepatitis C, Chronic | Hepatitis C virus genotype Infection | Hepatitis C virus RNA assay
Item
chronic hepatitis c, genotype 4-infection (hcv rna level greater than 1,000 iu/ml at screening)
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3])
Criteria Fulfill
Item
subjects must meet one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Therapy naive | Antiviral Therapy Absent Hepatitis C
Item
treatment-naive: subject has never received antiviral treatment for hepatitis c infection or
boolean
C0919936 (UMLS CUI [1])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Partial responder to therapy | Recurrent disease
Item
treatment experienced (prior null responders, partial responders or relapsers to pegifn/rbv);
boolean
C1875630 (UMLS CUI [1])
C0919875 (UMLS CUI [2])
C1740822 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
Postmenopausal state | Childbearing Potential Absent | Childbearing Potential Contraceptive methods
Item
females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Study Specified | Liver Cirrhosis Absent Biopsy of liver | Liver Cirrhosis Absent Fibroscan
Item
in substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or fibroscan
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4522043 (UMLS CUI [3,3])
Study Specified | Liver Cirrhosis Biopsy of liver | Liver Cirrhosis Fibroscan | Liver Cirrhosis Child-Pugh Classification | Liver carcinoma Absent
Item
in substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or fibroscan with child-pugh score less than or equal to 6 at screening and confirmed absence of hepatocellular carcinoma
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0023890 (UMLS CUI [3,1])
C4522043 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Hepatitis C virus genotype determination
Item
hcv genotype performed during screening indicating unable to genotype or co-infection with any other hcv genotype
boolean
C1533728 (UMLS CUI [1])
Laboratory test result abnormal
Item
abnormal laboratory tests
boolean
C0438215 (UMLS CUI [1])
Alcohol consumption Drink per day
Item
self-reports current drinking more than 2 drinks per day
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Study Subject Participation Status
Item
current enrollment in another investigational study
boolean
C2348568 (UMLS CUI [1])
DIRECT ACTING ANTIVIRALS
Item
previous treatment with a direct acting antiviral agent (daa) containing regimen
boolean
C3653501 (UMLS CUI [1])
Study Specified | Liver Cirrhosis
Item
in substudy 1, evidence of liver cirrhosis
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
Study Specified | Child-Pugh Classification | Liver carcinoma
Item
in substudy 2, evidence of current or past child-pugh b or c classification and confirmed presence of hepatocellular carcinoma
boolean
C2603343 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C4050412 (UMLS CUI [2])
C2239176 (UMLS CUI [3])